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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 MULTI HOLE ACETABULAR SHELL 48MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. R3 MULTI HOLE ACETABULAR SHELL 48MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71338663
Device Problem Unintended Movement (3026)
Patient Problem Joint Dislocation (2374)
Event Date 12/14/2017
Event Type  Injury  
Event Description
It was reported that the patient suffered an acetabular shell dislocation. The event was resolved with revision surgery. Cup has been destroyed and is not available for investigation.
 
Manufacturer Narrative
The associated complaint devices were not returned for evaluation. A review of complaint history's revealed no prior complaints for the listed lots. A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident. Our clinical/medical investigation reported the removed components were destroyed. Several attempts have been made to obtain clinical/medical documents to no avail. Without supporting clinical/medical documents a thorough investigation cannot be performed. Should information become available this complaint can be re-assessed. Without the actual product involved, our investigation cannot proceed. If the device or new information is received in the future, this complaint can be re-opened. No further actions are being taken at this time. We consider this investigation closed.
 
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Brand NameR3 MULTI HOLE ACETABULAR SHELL 48MM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, TN 38116
MDR Report Key7663695
MDR Text Key113184836
Report Number1020279-2018-01265
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K092386
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71338663
Device Lot Number17BM13252
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/17/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/05/2018 Patient Sequence Number: 1
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